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Wendy beats Goliath

Leonie

So, the trial of our friend Wendy ended earlier today – and guess what, she won. The truth finally prevailed over the malevolent entity that is GlaxoSmithKline (GSK). During the trial we heard how this drug company hid suicide events and misrepresented data that showed Paxil/Seroxat could induce suicide in adults as well as in children. GSK argued that rather than Paxil causing Wendy’s husband to die, it was the work related stress he was under. The jury saw through GSK’s defence and their so-called expert witnesses (one who was paid $165,000 for his testimony), and awarded Wendy $3 million. This vindication for the very charismatic Stewart, makes it a very good day.  Be careful when taking an SSRI antidepressant; this case showed how evidence-based-medicine may not be as scientific as we would all like to believe. Studies done by drug companies with vested interests in the outcomes, now who thought that was a good idea? News article courtesy of Law 360 below..

 

BREAKING: GSK Hit With $3M Verdict For Reed Smith Atty’s Suicide
By Jessica Corso

Law360, Chicago (April 20, 2017, 4:20 PM EDT) — An Illinois federal jury on Thursday found GlaxoSmithKline liable for the death of Reed Smith LLP partner Stewart Dolin and ordered the pharmaceutical giant to pay $3 million to the attorney’s widow, reaching the conclusion that a generic version of GSK’s Paxil caused Dolin to take his own life.

A nine-person jury agreed with Wendy Dolin that her husband had committed suicide in 2010 under the influence of generic paroxetine, an antidepressant sold as brand-named Paxil. (AP)
Following five weeks of trial testimony, the nine-person jury agreed with Wendy Dolin that her husband had committed suicide in 2010 under the influence of generic paroxetine, an antidepressant sold as brand-named Paxil. The jury awarded Dolin $3 million for the loss of income and the emotional distress she’s suffered since her husband ended his life by jumping in front of a Chicago train in the middle of a summer workday.

The verdict is a vindication of Dolin’s belief, expressed in her 2012 lawsuit, that her husband would still be alive if it weren’t for the paroxetine prescription he began taking days before his death.

Dolin said her husband was restless and agitated in the days leading up to his suicide, symptoms of a listed Paxil side effect known as akathisia. GSK denied any link between akathisia and suicide, but the widow said that the side effect sometimes causes people to act out violently and impulsively.

What’s more, the lawsuit claimed that GSK knew about the increased risk of suicide for adults taking paroxetine, particularly in the early days of treatment. Dolin said that the company had hidden data proving the link from the U.S. Food and Drug Administration for decades. She testified during the trial that while her husband was sometimes anxious, he had developed coping mechanisms to deal with that anxiety and was seeing a therapist at the time of his death.

GSK sought to pin the blame for Stewart Dolin’s death on his yearslong battle with anxiety, particularly as it revolved around his work as co-chair of Reed Smith’s corporate and securities practice.

Therapy records shown to jurors demonstrated that Dolin had expressed concerns with a therapist in 2007 about Reed Smith scooping up his then-firm Chicago-based Sachnoff & Weaver Ltd. GSK said that Sachnoff was a much smaller, single-office firm and that Dolin had felt unprepared to tackle BigLaw life.

“He didn’t feel qualified to do some of the work,” his then-therapist Sydney Reed said in a video deposition shown to the jury. “He had no experience with international law. He had no experience with giant corporations.”

Though the fears eventually dissipated, a GSK expert who examined the therapy records appeared on the stand during the last days of trial to say that Dolin’s insecurities flared up again in the last months before his death.

The economic downturn had “played havoc” on the corporate and securities practice group, which didn’t meet revenue goals for 2009, according to Dolin’s own review of the year. Because of that, GSK claimed, Reed Smith appointed a younger attorney to co-lead the group with Dolin, 57, who was previously the practice group’s sole leader.

Dolin also received anonymous negative comments on his year-end review and was struggling with a client unhappy with a lawsuit that another Reed Smith partner had filed, University of Massachusetts psychiatry professor Anthony Rothschild told the court.

“In some ways, his nightmare of being inadequate was coming true,” Rothschild said.

But the managing partner at Reed Smith’s Chicago office testified that it wasn’t work that drove Dolin to take his own life.

“He had a challenging week, but we sorted it through,” Mike LoVallo, who said he had known Dolin for decades and considered him a close friend, told the jury.

After he died, “I searched for anything else in his office,” LoVallo said. “I don’t think there was anything work-related that could have caused this.”

Wendy Dolin is represented by R. Brent Wisner, Michael L. Baum, Bijan Esfandiari and Frances M. Phares of Baum Hedlund Aristei & Goldman PC and David Rapoport and Matthew Sims of Rapoport Law Offices PC.

GSK is represented by Andrew T. Bayman, Todd P. Davis, Ursula Henninger and Heather M. Howard of King & Spalding LLP and Alan S. Gilbert and Anders C. Wick of Dentons.

The case is Dolin v. SmithKline Beecham Corp. et al., case number 1:12-cv-06403, in the U.S. District Court for the Northern District of Illinois.

–Editing by Christine Chun.

Adverse Reaction to SSRIs, Dolin v SmithKline Beecham, Iatrogenesis, Paroxetine, Paxil, Random, Seroxat

GSK’s Dirty Little Secret

Leonie
Stewart
Dolin v SmithKline Beecham

So, myself and my friend Stephanie were in Chicago this week. We had traveled across the Atlantic to hear the opening arguments of Dolin v. Smithkline Beecham Corp (now GlaxoSmithKline – GSK). For more background to this case, see here.

We arrived straight into an unprecedented weather event, Storm Stella – described in the media as a weather bomb, having undergone bombogenesis (haven’t a clue either). Thus, while we were a little worried that the trial might be postponed, we were more concerned with the liklihood of two Irish females freezing to death. However, despite hitting a cool minus-8, with some pretty bizarre white-out conditions, we survived and the trial went ahead as planned (with the Hon. William T. Hart presiding).

This case centers on Wendy Dolin, the plaintiff, alleging that her husband’s death in 2010 was drug-induced and that GSK failed to warn of the increased risk of suicide in older adults taking the antidepressant Paroxetine. Her lawyers, Baum Hedlund, contend that GSK hid a ‘dirty little secret’ – that the drug can cause akathisia, often coded under the innocuously-sounding ‘inner turmoil’. However, this drug-induced condition is far from harmless and injury to oneself and/or others, can quickly follow. Furthermore, as alleged in this case, it can often prove fatal; see here.

At the time of his death, Stewart Dolin was 57 and was a corporate lawyer with ReidSmith. While suffering from work-related stress, he was prescribed Paroxetine by his physician, Dr. Martin Sachman – a family friend. Paroxetine is perhaps more widely recognised by its trade name Paxil, or Seroxat in Europe. Six days after being prescribed a generic form of the drug, Stewart died by jumping in front of a Chicago train. He was affluent, well-liked by colleagues and well-loved by his family. Per one of his colleagues “Stu Dolin was a close personal friend, valued colleague and a great leader in our firm. His energy and spirit benefited everyone around him. The lawsuit claims that GSK failed to adequately warn doctors (including Dr. Sachman) of the increased risk of suicidal behavior in adults. Indeed, GSK’s opening argument proclaimed that ‘Paxil does not cause suicide’. That was then contradicted by GSK’s very own literature, where a 2006 analysis showed a 6.7 times greater risk of suicidal behaviour in adults (of all ages) taking Paxil, over placebo.

Doctor David Healy was on the stand for 2 full-days, as an expert witness for the plaintiff. His testimony included an account of how GSK had hidden suicide events from the Food and Drug Administration (FDA), thus manipulating the suicide-ratio and effectively hiding the bodies. Explaining drug-induced suicides to the jury, his world-leading expert status in psychopharmacology was unquestionable. No doubt, GSK ‘s legal team will attempt to annihilate that particular status before he exposes any more ‘dirty little secrets’. Like how 100% of Paxil consumers will experience sexual dysfunction – another life changing adverse-effect he mentioned in court, and another one not precisely admitted to by the manufacturers.

Not surprisingly, GSK’s lawyers (King and Spalding), became increasingly apoplectic, interjecting every few minutes with their objections, which proved fascinating in itself. The last hour before the court adjourned for the week-end proved to be very enlightening indeed, with their team looking increasingly agitated. Doctor Healy was then asked some questions by the plaintiff’s legal team:

(1) Do you have any doubt that Paxil can cause suicide? He answered ‘No’.

(2) In your opinion, did GSK warn doctors of the increased risk of suicide in adults? Again he answered ‘No’.

There seemed little doubt to anyone listening that Paxil could cause Akathisia and/or a drug-induced suicide. However, no doubt GSK will have many experts to refute that, whatever the evidence has shown. Having listened to this week’s testimonies, there is absolutely no doubt in my mind that Steward Dolin’s death was induced by the Paxil he was taking in the final 6 days of his life. However, the trial will most-likely go on for another few weeks when the jury will ultimately decide. Sadly, as is normal in these legal cases, every aspect of Wendy and Stewart’s private life will be publicly torn to shreds, with their every move dissected to try and put doubt into the jury’s mind. Whatever the outcome, Stewart’s wife Wendy, is one very, very brave lady.

Clearly, GSK’s lawyers are particularly polished and well used to court proceedings. That said, following the jurys’ retirement for the weekend, there was a last minute crucial objection from their legal team. One of their lawyers raised a final grievance – that a lawyer for the plaintiff’s side had the cheek to say ‘have a good weekend’ to the jury. Seriously? Drug induced suicide was the issue here and this farewell gesture caused offence to GSK’s legal team?

Anyway, if you would like to see the three video depositions that were shown to the court; they were uploaded yesterday. You really don’t need to be a body language expert to determine how truthful these GSK experts are being – or not.

GSK Biostatistician John Davies Deposition in Paxil Suicide Case:

Damning Testimony from Former GlaxoSmithKline CEO Jean-Pierre Garnier in Paxil Suicide Case:

Former Glaxo Executive Jeffrey Dunbar Deposition in Paxil Suicide Case:

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Jake’s Mammy on DriveTime

Leonie

For anyone who hasn’t heard of Jake McGill Lynch, age 14, who died following a prescription for Fluoxetine (Prozac), here’s his mom Stephanie being interviewed on RTE Radio. The journalist, Della Kiroy, also interviewed David Healy who speaks towards the end of the programme. Stephanie’s harrowing account of Jake’s life and death is a warning to all that antidepressants are far from harmless, particularly when prescribed to children. Despite the widespread antidepressant prescribing in Ireland, the European Medicine’s Agency has provided the following warning  –

“..suicide-related behaviour (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with these antidepressants compared to those treated with placebo. The Agency’s committee is therefore recommending the inclusion of strong warnings across the whole of the European Union to doctors and parents about these risks. Doctors and parents will also be advised that these products should not be used in children and adolescents except in their approved indications.”

A recent study by Sharma et al also found similarly. The study found that in children and adolescents taking antidepressants (SSRIs and SNRIs), the risk of suicidality and aggression doubled. Being aware of all the risks and benefits is crucial before deciding whether (or not) to take a pill – any pill. Knowing what to look out for may just save a life – it may well have saved Jake’s.

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Victor Kirk – Coincidental SSRI Prescription?

Leonie

 

 old-man-taking-pills

Some cases, like this one, are so clearly antidepressant-induced that it seems bizarre that a coroner or medic couldn’t (or wouldn’t) recognise it. That suicidality is a side-effect of antidepressants is now well established, particularly upon starting, changing dose (up or down) or discontinuation. While the suicide-warnings are provided for under 25s, it is apparent that age is irrelevant when suffering an attack of antidepressant-induced akathisia, aggression, emotional blunting, mania or suicidal ideation (all in the leaflet).

The following case has all the hallmarks of being drug-induced. The timeline and details of events, including the flu-like symptoms and repeated interactions with the doctor, struck me as being very similar to the circumstances surrounding Shane’s death (my son). These out-of-the-blue, uncharacteristic, violent deaths have been happening for decades, since the introduction of Selective Serotonin Reuptake Inhibitors antidepressants (SSRIs). In my opinion Victor is clearly another SSRI victim.

 

Victor, age 71.

Victor Kirk, 71, was suffering from high blood pressure and heart disease. On July 6th, he attended his doctor as he was feeling faint. This was possibly caused by his blood-pressure medication, as reports state that his dose was reduced for a short period and subsequently increased. There is no suggestion that Victor had any history of depression; however, he was prescribed an antidepressant for his ‘low mood’.

Less than 3 weeks later, on July 25th, Victor returned to his doctor complaining that he was suffering from side-effects of the antidepressant medication. He was switched to a different antidepressant and told to come back the following week. On August 11th, Victor once again returned to his doctor as he was ‘very worried’ about his health and felt he was getting a chest infection; he was prescribed an antibiotic. 3 days later, on August 14th, he expressed suicidal thoughts.

On the morning of August 17th, 6 weeks after he was first prescribed an antidepressant, Victor wrote a suicide-note. He then took a circular saw into his bathroom and used it to kill himself. Awakened by the loud noise, Victor’s wife found him dying on the bathroom floor, covered in blood. The coroner recorded a verdict of suicide. It looks like there was no discussion as to why Victor, who lived for 71 years and had no history of mental illness, would choose to end his life in this horrific manner. Yet again, it seems there was no discussion on his recently prescribed mind-altering-drugs, which an unwitting Victor had flagged before his death. While a coroner might be excused, as he/she often has no medical background, it is a travesty when medics ignore what is staring them right in the face.

Timeline:

July 6th – Went to GP feeling faint, prescribed an antidepressant for low mood.

July 6th-25th – Routine checks during July.

July 25th – Returned to GP complaining of side-effects. Antidepressant was stopped and replaced with a different brand.

August 11th – Returned to his GP again, very worried about his health.

August 14th – Mr Kirk expressed suicidal thoughts.

August 17th – Used a circular saw to end his own life.

GloucestershireLive Article.

Random

The Destigmatization of Stigma ..

Leonie
al-porter
Stigma: a mark of disgrace associated with a particular circumstance, quality, or person – “the stigma of mental disorder”. 

 

Comedian Al Porter was on Irish TV this week, speaking of his depression, the one brought about by his chemicals that needed re-balancing. He spoke of the stigma attached to depression, then whipped out his pills on live TV and ended with the recommendation that if people needed meds, go get them, they work. The two other guests (a journalist and a doctor) were visibly moved, with one on the verge of tears, both saying how marvellous Al was for speaking so openly about his depression. Yet no-one on the programme, not even the doctor, contradicted him on his unfounded chemical imbalance belief. No balancing scientific argument was made to say that psychotropic drugs, which target the brain, can increase the risk of suicidal behaviour and aggression. Oh and let’s not forget the high percentage that will experience antidepressant-induced sexual dysfunction (sometimes irreversibly).

I’m glad the drugs worked for AL, really I am, he seems like a nice fella. Good luck to him – I only wish they worked so well for everyone. He’s on meds though, so what, who isn’t? You don’t see fertile females whipping out their oral contraceptives, shouting “I’m on the jack and jill, aren’t I feckin marvellous?” Or, half the population whipping out their benzos, screaming (albeit calmly) “long live me auld psychotropics”. Only the locale-name is already familiar, Ireland could surely be re-named ‘Statin Island’, which consumers could also whip out – if they could remember where they put them.

Stigma, stigma, stigma. It’s a word being wildly bandied around in the media, demonstrating how thoroughly modern and enlightened we all are. Al spoke of feeling a stigma attached to taking medication. Whether this stigma actually still persists, is debatable, particuarly as there are approximately 500,000 Irish people currently taking antidepressants or anti-anxiety drugs. According to the Irish Medical Organisation (IMO), 25% of Irish adults are suffering from a mental health disorder (IMO, 2016). Across the European Union, the European College of Neuropsychopharmacology (ECNP) have estimated the number to be far higher, at 38.2%. Everywhere we look, there are articles and documentaries informing us that having a ‘mental health’ issue, particularly depression, is actually quite normal. Indeed, the Pharmaceutical industry has spent years attempting to normalize mental illness. Yet, why would industry spend so much time and effort into supposedly reducing mental health stigma. Depression, being an extremely lucrative market, is hardly co-incidental?
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Destigmatizing stigma.
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One Pharma initative, Lundbeck’s ‘Art Against Stigma‘, apparently aims to create a ‘better understanding of mental illness’ and challenge the general public ‘to re-evaluate their perception of those with mental illness’. They very kindly provide a list of the drugs they manufacture for every mental illness you can imagine, down at the bottom of the leaflet. Ahead of another Lundbeck initiative, Irish psychiatrist Patricia Casey, a paid speaker for many years with this Pharmaceutical company, said –
people with depression can often suffer for years before seeking treatment because they do not recognise the condition or because they do not want to be stigmatised.
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GlaxoSmithKline also got in on the stigma train. Having done a fabulous job on this side of the water normalizing ‘mental illness’ (and touting GSK drugs), it took its de-stigmatising project (and drugs) to Japan, with their advertising slogan “Does Your Soul Have A Cold?” No doubt a dose of Paroxetine (Seroxat/Paxil) will cure your mucus-filled soul – perhaps permanently.
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 Not to be outdone, Lilly also got in on the act with ‘The Welcome Back Awards‘ program, established to ‘recognize outstanding achievements in the fight against depression and the stigma often associated with the illness’. Of course Lilly’s Fluoxetine (Prozac) was a major part of its success. It’s interesting to note, that stigma did not cause the death of 14-year-old Irish boy, Jake McGill Lynch – Prozac did.
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Depression is big business for the drug industry. If there is any remaining stigma, directed at a person in distress or otherwise, that is ignorance – not stigma. A pill will not cure ignorance. The Pharmaceutical industry sells drugs – an industry that exists because of ‘illness’, not health. An industry push to destigmatize ‘mental illness’ is similar to Diageo attempting to destigmatize alcoholism.
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RCSI Psychiatry and The Serotonin Myth

Leonie
journey-through-the-brain
Yesterday the Royal College of Surgeons in Ireland (RCSI) launched an eBook entitled ‘journey through the brain‘ – to explore ‘the science of the brain and its connection to human emotion, mental health and well-being’. Created by researchers from the Dept of Psychiatry, the book was designed to help young people and teachers ‘understand the workings of the brain through pictures and cartoons’. The Irish Times Magazine reports that the book brings us ‘up to speed with with the latest research into the mysterious workings of our little gray cells’. This latest research from the RCSI (ranked as one of the top Universities in Europe), was designed to help us understand neuroscience and mental health – what could be better?
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Much to my disgust, the book once again pushes the unfounded chemical imbalance theory, stating ‘there is evidence for decreased levels of serotonin in the synapse of people suffering from depression’. As copies will be distributed to second level schools throughout Ireland, rather than being educational, it’s actually providing a tool for misinformation. It’s not the first time the psychiatry department has publicly expressed a belief in the now-debunked chemical imbalance myth (see Tweet here) and it’s not the first time I have challenged it within the College. As a mature student in the RCSI, I thought I could point out this obvious, very sloppy, error and they would address and amend their mistake forthwith – alas, I’m still waiting for a response to last year’s query.
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No doubt you may be wondering why I feel I’m right and the experts in RCSI Psychiatry have got it wrong? I’m open to contradiction and would be delighted to see this ‘evidence’ of low serotonin – a veritable medical revolution. However, in anticipation of debate and as previous experience had shown there was little necessity for haste, this time I took the liberty of asking the experts to confirm that the above statement is, in fact, rubbish.
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David Healy, psychiatrist, psychopharmacologist, scientist and author confirmed that yes, the low-serotonin theory is rubbish. He said rather than learning about neuroscience, readers will instead be ‘dupes of marketing’. His recent BMJ article ‘Serotonin and Depression’ provides greater clarity.
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Peter C. Gøtzsche, physician, medical researcher, leader of the Nordic Cochrane Center and co-founder of the Cochrane collaboration – yep, rubbish (and a very harmful lie, as it keeps people on drugs they would rather stop).
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Robert Whitaker, medical & science journalist and author – yep, ‘total nonsense’. He referred to a much-cited article by well-known U.S. psychiatrist, Ronald Pies (former editor of The Psychiatric Times), who opined “In the past 30 years, I don’t believe I have ever heard a knowledgeable, well-trained psychiatrist make such a preposterous claim, except perhaps to mock it”.

So there you have it; not since the days of shoulder-pads and leg-warmers has Professor Pies heard such preposterous claims, yet in 2016 the RCSI Dept of Psychiatry are still sticking to the low-serotonin mantra.

I should point out, that as a mature student, studying in the RCSI is an amazing experience. I love the camaraderie there, and the integrity of the lecturers (and students) is unquestionable. There are even a couple of perfectly nice psychiatrists. However, there is no excuse for ‘educating’ people in a ‘chemical-imbalance’ basis of depression – despite vast research, it remains unproven. Furthermore, it gives vulnerable people the impression that they have an inherent deficiency, one that only drugs can fix. This dangerous propaganda is a theory invented by industry, a very lucrative one and one that has no scientific basis whatsoever.

Recently the RCSI was given the task of defining ‘Medical Professionalism’ in order to achieve excellence in education. Entrusted into the hands of RCSI psychiatrist, Prof Kieran Murphy – a very fine document emerged. One criterion, is that medics exercise ‘evidence-based-practice’. So, with the repeated spouting of chemical imbalances and low serotonin, could it be that there is a different set of rules for the RCSI’s Dept of Psychiatry? Perhaps evidence-based-practice does not apply to this particular medical field.

Inexcusable.

Adverse Reaction to SSRIs, lundbeck, Newspaper and internet articles

The Pill That Steals Lives

Leonie

London July 2016

This week myself and Tony abandoned the minors, left them in the care of the (sergeant) majors and took ourselves off to London. With promises of presents and various forms of bribery, they waved us off without a second glance – the deals were struck. With one condition – as long as we were back for Henny-Benny’s 12th birthday on Wednesday, we could do whatever else we liked. The purpose of our trip overseas was to attend a book launch in Waterstones of Kensington – Katinka Blackford Newman’s ‘The Pill That Steals Lives’. Having read excerpts in the Mail and spoken to Katinka over the last year, I was really looking forward to it.

Katinka is a film producer, director and author – she’s also attractive, clever and extremely funny (as are her 2 amazing children). Her book depicts a particularly harrowing year in her life, a year that started with a marriage break-up and a prescription for Escitalopram (Lexapro/Cipralex). She describes, in painful detail, her subsequent spiral into an emotionally-blunted, chronically-fatigued, medicated shell of her former self. Weirdly, as a result of running out of health insurance, she survived to tell this tale. Her autobiographical account of that year is told in a sometimes tragic, yet often humorous way – this book is a stunner. Considering the enormous increases in antidepressant prescribing, for every conceivable ailment (from exam woes to shyness), I hope it is read far and wide.

We had arranged to meet up with our friends before the book launch (Brian, his better half and Bobby Fiddaman). Brian and the Mrs were staying in a very posh hotel, where the concierges wore top hats and tails – we weren’t. A previous fiasco in Denmark led them to choose their own hotel this time – but that’s another story. Nevertheless, the concierge was very friendly and courteous and after equally posh aperitifs, we all travelled together to Waterstones bookshop on Kensington’s High Street.

It was fabulous. We met other Irish friends there too – Stephanie and John Lynch, whose son Jake tragically died from an antidepressant-induced death at age 14. There were people from all corners of the globe, all with similar stories to tell. I was delighted to finally meet David Carmichael, who had travelled from Canada to be there. David strangled his 11-year-old son while in a Seroxat induced psychosis – he’s a very nice man and I would trust him with my life.

Kirk Brandon, a singer and friend of Bobby’s was there too. While having Lunch the following day, Kirk told an equally harrowing story of his time on Seroxat. There are so many stories, from survivors (the lucky ones) but equally from those who didn’t survive, like Shane, Kevin, Jake, Ian, et cetera. The list goes on and on – read the book.

As is the norm for us in London, we had a few hiccups along the way. Thankfully, there was no flashing of ageing bodily parts this time around, certainly not mine anyway (I can’t speak for the others). Although, getting peed on, first by torrential rain and then by Ryanair, wandering aimlessly around London in the middle of the night (due to a raging fire near Clapham Junction) was all par for the course.

Even an impromptu overnight stay in London City Airport, coupled with additional flights costing a further 600 euro, could not dampen our spirits. It was worth every penny, although we did put ourselves in jeopardy of additional bribery – we missed Henny-Benny’s birthday. All is not lost though – he’s busy concocting up a repayment scheme for the trauma of this particularly bad parenting.

The Pill That Steals Lives.

Iatrogenesis

When Science and Anecdote Collide

Leonie

cropped-hippocrates12.jpg

For decades, declarations by perturbed relatives that a loved-one’s death was iatrogenic (induced by medical treatment), were often dismissed as anecdotal. Accounts imparted by concerned loved-ones were likely to be rejected, albeit often kindly – yet thrust aside as the demented rantings of a grieving loved-one. Placated with persuasive words, relatives often slink away, suitably chastised by the medic’s evidential superior knowledge. The rantings of the grieving widow or mother will be controlled and placated, with the vociferator patronized and often pitied as misinformed dissidents. Thus, relegated to the anecdotal tray, rather than adverse-reaction tray, the iatrogenesis will likely continue, surfacing some time later to harm another. Many feel this practice is particularly pervasive within psychiatry, where protecting the medical model seems paramount over the safeguarding of patients.

The perception of the American ‘shrink’ listening attentively, while the horizontal patient spills his innermost torment, is one that persists today. In reality, this is far from the norm, with the prescribing of psychiatric drugs taking precedence over the tedium of treating a traumatised patient. Drugs that often mask the problem with disinhibition and emotional blunting are seemingly prescribed with wild abandon, yet only the families affected can see the harms done – while medics seem oblivious. When Cochrane Scientists and expert psycho-pharmacologists, are publicly stating that antidepressants and other psychotropic drugs are causing ‘more harm than good’ and many deaths, dismissive medics who continue to recklessly prescribe are walking a fine line between acting irresponsibly and negligently. However, a vast disparity still exists between scientific findings that psychiatric drugs are the third leading cause of death in Europe (and the U.S) and psychiatry’s Key Opinion Leaders (KOLs) declaring these drugs are safe – even declaring that ‘the public should have no concerns about these drugs’. 

When publicly challenged, KOLs usually retaliate with the mantra ‘correlation does not imply causation’. Pushed a bit further, their hackles will rise and they’ll state ‘these people are causing harm, by stopping people from taking life-saving medication’. Yet, even a utilitarian argument that these drugs provide ‘the greatest good for the greatest number’ has been debunked by Peter Gøtzsche (scientist and co-founder of the Cochrane Collaboration). He stated recently, to no small uproar, that these drugs are ‘doing more harm than good’ and that almost all psychotropic drug use could be stopped without deleterious effect (due to withdrawal, discontinuing is not advisable without medical supervision).

However, the problems run deeper than the KOLs defence of psychiatric drugs. An interesting article on MIA (Mad in America) tells the sorry tale of a dad who recently discovered that the American drug regulator (FDA) is ‘hiding reports linking psychiatric drugs to homicides’. It will be interesting to see what happens next within the FDA.

Furthermore, the statement that ‘the public should have no concerns about these drugs’ was made following an inquest in Ireland, where concerns were raised by the deceased’s family about a recent prescription of Sertraline (Zoloft/Lustral). However, as is common practice, the family’s concerns were dismissed. They had no way of knowing that in 1998, the Irish Drug Regulator (HPRA), following reports of Sertraline-induced suicide, had requested that the drug company in question (Pfizer) search its database for similar cases. There were 594 ‘suicide events’ reported from non-clinical sources, of which causality was not investigated. Of the 252 from clinical trial cases, Pfizer’s internal report concluded that 54 were directly related to Sertraline treatment. Interestingly, 11 of the ‘suicide events’ reported (from both sources) came from Ireland, with 2 found causally related to Sertraline. The latter were from ‘confidential’ documents released through court proceedings and provided by Kim Witczak who lost her husband Woody to Sertraline.

Nevertheless, it seems that science may be catching up with the anecdotal evidence, with some interesting studies published recently. Following the Study 329 debacle (as yet unretracted), the latest study by Jureidini et al ‘The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance’ shows how Forest Labs, through greed and fraudulent practices, actively ignored the prospective likely harms to children. The study concluded:

Deconstruction of court documents revealed that protocol-specified outcome measures showed no statistically significant difference between citalopram and placebo. However, the published article concluded that citalopram was safe and significantly more efficacious than placebo for children and adolescents, with possible adverse effects on patient safety.

Another study by Selma et al ‘The relevance of cytochrome P450 polymorphism in forensic medicine and akathisia-related violence and suicide’ expressed that a genetic predisposition to iatrogenesis can be traced back to pharmacogenetic interactions, namely the inability of some to metabolize prescribed drugs, making ordinarily ‘safe’ drugs, lethal for some. The study concluded:

“CYP450 status is an important factor that differentiates those who can tolerate a drug or combination of drugs from those who might not. Testing for cytochrome P450 identifies those at risk for such adverse drug reactions. As forensic medical and toxicology professionals become aware of the biological causes of these catastrophic side effects, they may bring justice to both perpetrators and to victims of akathisia-related violence. The medicalization of common human distress has resulted in a very large population getting medication that may do more harm than good by causing suicides, homicides and the mental states that lead up to them”.

Perhaps we will just have to wait for the hapless KOL to catch up, not only with the scientific evidence but with collective anecdotal evidence from families. It would seem that underestimating anecdotal evidence is unwise – not least as science often evolves from this very valuable source.

The citalopram CIT-MD-18 pediatric depression trial: Deconstruction of medical ghostwriting, data mischaracterisation and academic malfeasance.

The relevance of cytochrome P450 polymorphism in forensic medicine and akathisia-related violence and suicide

Family calls for more research into anti-depressants

The FDA Is Hiding Reports Linking Psych Drugs to Homicides

Newspaper and internet articles

GSK and The Miracle Med – The Happy Horny Skinny Pill

Leonie

Skinny fat pic

An article in Sunday’s Telegraph ‘could antidepressants be ruining your sex life?’ concerned the use of widely-prescribed SSRIs (Selective Serotonin Reuptake Inhibitors) and the associated loss of libido. The article rightly refers to statistics that estimate between 30-70 per cent of SSRI consumers will be affected with some form of sexual dysfunction – despite their much-argued efficacy. According to Peter Gøtzsche, Cochrane scientist, “There isn’t much happiness in the pills. Their most pronounced effect is to cause sexual disturbances…The drugs should therefore have been marketed as a formidable disrupter of your sex life, but that wouldn’t have sold many pills.” 

However, the Telegraph article also conveyed common misconceptions into the psychopharmacological workings of antidepressants. In a nutshell – by increasing the levels of happy neurotransmitter serotonin, this effectively lifts overall mood but as a result of this increased serotonin level, your libido will decrease along with the ability to orgasm. It seems, despite there being no way of quantifying serotonin (at least not when alive), belief in ‘the chemical imbalance myth’ still prevails.

Nevertheless, leaving aside the legend of the chemical imbalance, the article also discusses another ‘libido-friendly’ alternative to SSRIs, GlaxoSmithKline’s Bupropion/Wellbrutin. The author seemingly expounds the virtues of this drug, marketed in the U.S. as Wellbutrin (an antidepressant) and Zyban (an anti-smoking drug) in the U.S. and Europe. Excerpt:

“It seems that instead of dampening desire, Wellbutrin can increase libido and suppress appetite, earning it the nickname of the ‘happy, sexy, skinny pill’.  

Sounds like the perfect pill, if it actually worked. In case anyone was contemplating doing a bit of self-diagnosing and self-medicating via the internet (as the article reports many U.K. women are doing), there are other factors that just might put you off. In fact, some crucial Wellbutrin-related adverse effects were omitted from the article, f0r example, some very serious psychological effects: unusual thoughts and behaviors, increased risk of suicidal behaviour, aggression, delusions, seizures, hallucinations, paranoia, confusion and manic episodes.

In reality, this so-called ‘happy, sexy, skinny pill’ has been plagued with problems. Following significant incidences of seizures, Wellbutrin was taken off the market shortly after its initial approval – but re-introduced a few years later at a lower dose. In 2009, following numerous suicides, the FDA (US Medicine’s Regulator) was so concerned about the psychological effects of Wellbrutin/Zyban in smokers, that they ordered a further black-box warning to be attached. The following year (2010), a study by Moore et al ‘Prescription Drugs Associated with Reports of Violence Towards Others’ found Wellbutrin to be one of the 31 drugs disproportunately associated with violence.

Furthermore, as for being nickednamed the ‘happy, sexy, skinny pill’ there is one main reason for this – money. In fact, GSK actively promoted Wellbutrin as ‘the happy, horny, skinny pill’ and paid handsomely for promoting the drug for unapproved uses. In an action taken by the U.S. justice department, allegations included a myriad of wrongdoings, including that GSK hired PR firms to promote off-label use, paid doctors, organised sham advisory boards, sham ‘independent’ medical education events and provided samples to pediatric psychiatrists for unapproved use in children (despite knowing it increased the risk of suicide in this age group).

On one particular radio show, well-known tv-doc, Drew Pinsky, said it was possible that Wellbrutin could have caused a female caller’s ’60 orgasms a night’ (Sure, you’d be worn out – and I’m not entirely sure why this wouldn’t be conceived as a downright affliction). Anyway, dear Dr Drew never clarified this or mentioned that he was paid, very, very handsomely, for his services to GSK. In the months before the radio show, GSK indirectly paid him $275,000 – a fact not disclosed to the listeners. Thus, an internal GSK report determined that the media campaigns pushing Welbutrin’s ‘happy, horny, skinny’ effects, reached a total audience of 387 million. It would be surprising if anyone hasn’t heard of it, even on ths side of the Atlantic.

In case you need further convincing, in 2012, GSK was fined 3 billion dollars for these illegal and dubious practices, including for the off-label and harmful promotion of Wellbutrin in children and adults. Nevertheless, as the sales for Wellbutrin during that same period, were reportedly $5.9 billion, GSK made a tidy profit. The collateral damage of  harmed kids and unsuspecting consumers went seemingly unnoticed.

So, I would be very careful of that so-called miracle cure – you just might get more than you bargained for. ‘Sickness’ is a very lucrative business and all pharmaceuticals companies are corporate entities, ones that are totally reliant on sickness, not health. GSK just so happens to be bigger than most and one that has shown itself time and again to use greater bullying tactics.

Telegraph Article – Could Antidepressants be Killing your Sex Life?

New York Times – Suicide Warnings for 2 Anti-Smoking Drugs.

Prescription Drugs Associated with Reports of Violence Towards Others, Study.

Justice Department Complaint, courtesy of KHN, here.

New York Times – Glaxo Agrees to pay $3 Billion in Fraud Settlement.

Random

Lundbeck Astroturfing

Leonie

Lundbeck's Expert Panel, Madrid

There has been much publicity recently on the alcohol industry and their sponsorship of sporting events. I won’t rehash the numerous arguments here but suffice to say, most agree that it’s an unethical alliance. An article by Dr John Scally, TCD (and RCSI) lecturer in Ethics and Theology, expressed the view that there are particular ethical issues involved when accepting sponsorship from the alcohol industry. He stated “No drug has caused more damage to Irish families than alcohol. Of course, the Guinness sponsorship of the hurling championship did not force young people to drink alcohol. Yet it would be naive in the extreme to think that executives of alcohol companies would fork out huge sums of money on sports sponsorship unless there was some boost to their sales in return”. 

To be honest, I’m not really sure what all the fuss is about – there’s no subterfuge, it’s a self-explanatory and transparent relationship. It seems to me that there are far worse examples of industry-funded events, ones that are far from transparent. What of Pharma-funded awareness programmes, companies that just so happen to have a drug that might (or might not) help the same condition they’re creating awareness for? A recent article in Spain’s El País Newspaper (unwittingly) provides an insight into the unethical subterfuge that can often exist behind ‘awareness’ programmes. The article ‘Three-quarters of at-risk drinkers in Spain unaware of dangers of alcohol’ gives a stark warning to Spanish drinkers who ‘consume worrying amounts of booze’. The article comes on the back of a survey done by Danish pharmaceutical company Lundbeck, which was presented by a panel of experts to a symposium in Madrid last week. Following the study on alcohol consumption, the panel of experts called for legislation to regulate alcohol intake, limit access to alcohol and control alcohol-industry advertising. The El País article ends with the line “Each day, the industry spends a million euros promoting alcoholic drinks. This is not ethical.” Okay so far – many would agree that spending a fortune in promoting alcohol products is an unethical practice.

What the article doesn’t say, is that –

  1. Lundbeck, the Pharmaceutical company behind the survey, (coincidentally) manufactures a drug for alcohol dependence, Nalmefene.
  2. Each expert from the panel has many conflicts of interest, including receiving numerous ‘honoraria’ from Lundbeck – all have a vested (and potentially very lucrative) interest in their submissions. Honoraria (plural of honorarium), a confusing word, meaning cash for services rendered.

The Panel of experts –

Julio Bobes, president of Socidrogalcohol, a research organization into alcohol and drug dependence. His conflicts of interest includes receiving honoraria from Lundbeck and being part of the ESENSE 2 Study, a randomized controlled 6-month study of ‘as-needed Nalmefene’, sponsored by Lundbeck.

Antoni Gual, of Barcelona’s Hospital Clinic. His conflicts of interest include- AG has received honoraria, research grants and travel grants from Lundbeck. He wrote numerous Nalmefene papers, including this one he co-wrote with employees of Lundbeck – ‘A randomised, double-blind, placebo-controlled, efficacy study of nalmefene, as-needed use, in patients with alcohol dependence’. Lundbeck was involved in the study design, data collection, data analysis, and interpretation of the data. AG was also on the advisory board of Socidrogalcohol.

José Ángel Arbesú of the Spanish Association of Primary Care Medics. His conflicts of interest include being an advisor to Lundbeck and obtaining Lundbeck funding for research, publications and training. He took part in the following study ‘SEMERGEN positioning for the treatment of alcohol disorders in primary care’ with Julio Bobes and Antoni Gual – a study that recommended Lundbeck’s Nalmefene for reducing alcohol consumption.

Javier Zarco of the Spanish Society for Family and Community Medicine, has consulted and obtained funding for advice, research, publications and training activities from Lundbeck.

In 2014 the college of psychiatrists of Ireland called for a ban on Alcohol advertising and sponsorship; it seems ironic that they do not see the glaringly obvious similarities between the latter and the pharmaceutical industry’s funding of academia and of the very studys that medics rely on for basic education. One wonders why the college would focus on sponsorship by the alcohol industry and ignore their own professions alliance with, and allegiance to, the pharmaceutical industry.

El País Article.